Effects of inhaled hypertonic saline in children with cystic fibrosis
| ISRCTN | ISRCTN13412080 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13412080 |
| Secondary identifying numbers | 01 |
- Submission date
- 04/05/2016
- Registration date
- 06/07/2016
- Last edited
- 19/10/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Genetic Diseases
Plain English summary of protocol
Background and study aims
Cystic fibrosis (CF) is an inherited condition which causes the lungs and digestive system to become blocked with mucus. It is caused by a faulty gene, which is responsible for controlling the movement of water and salts in and out of cells. This leads to a buildup of sticky mucus which clogs the lungs and airways causing breathing difficulties and lung infections, and the digestive system which affects the way food travels through and the ability to absorb nutrients from it. Most people with CF experience problems with lung function and usually are treated with a combination of physiotherapy and medications to prevent lung infections and the buildup of mucus that causes damage. Bronchodilator medications are commonly used in the treatment of CF, as they make breathing easier by relaxing the muscles in the lungs and widening the airways. Following bronchodilation, patients are often given normal saline (salt water) through a nebulizer in order to bring up the mucus blocking their lungs. The aim of this study is to investigate the effectiveness and safety of using hypertonic saline (a solution which is more concentrated than in the body) in children with CF.
Who can participate?
Preschool aged children with cystic fibrosis being treated using bronchodilators and physiotherapy.
What does the study involve?
Participants are randomly allocated to one of two groups who receive two treatments for 16 weeks in a different order. The first treatment involves inhaling a mist of 4ml normal saline (salt water), twice a day for 16 weeks. The second treatment involves inhaling a mist of 4ml hypertonic (more concentrated than blood) saline, twice a day for 16 weeks. At the start of the study and then again after 4, 16, 20 and 32 weeks, participants in both groups complete a number of breathing tests (involving breathing into a machine in various ways) in order to measure how well their lungs are working. Throughout the study, any side effects experienced by the children are recorded on a questionnaire.
What are the possible benefits and risks of participating?
There is a possibility that participants may benefit from improved breathing and lung function. There are no notable risks involved with taking part in this study,
Where is the study run from?
Sapienza University of Rome (Italy)
When is the study starting and how long is it expected to run for?
February 2010 to February 2015
Who is funding the study?
Policlinico Umberto I (Italy)
Who is the main contact?
Dr Rafaella Nenna
Contact information
Scientific
Department of Pediatrics and Pediatric Neuropsychiatry
Sapienza University of Rome
Viale Regina Elena 324
Rome
00161
Italy
Study information
| Study design | Double-blind randomised cross over trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No specific participant information sheet available, please use the contact details below to request a further information. |
| Scientific title | Effects of inhaled hypertonic (7%) saline on lung function test in preschool children with cystic fibrosis: a crossover, randomized clinical trial |
| Study objectives | The aim of this study is to evaluate whether inhaled hypertonic saline is effective and safe in children with cystic fibrosis. |
| Ethics approval(s) | Scientific Ethics Committee, Policlinico Umberto I, 11/03/2010, ref: HS-2009-Prot.1818(11/03/2010) |
| Health condition(s) or problem(s) studied | Cystic fibrosis |
| Intervention | Participants are randomly allocated to one of two groups who receive two treatments in a random order. Treatment 1: Participants receive inhalatory administration of 4ml hypertonic saline (HS - 7 % sodium chloride) twice daily for 16 weeks Treatment 2: Participants receive inhalatory administration of 4ml normal saline (NS - 0.9 % sodium chloride) twice daily for 16 weeks There is no washout period between the two treatments, and children are followed up after 4, 16, 20 and 32 weeks. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Hypertonic saline |
| Primary outcome measure | 1. Airways resistance was measured using interrupter resistance technique at baseline, 4, 16, 20, 32 weeks 2. FVC, FEV1 and FEF25-75 were measured using spirometry at baseline, 4, 16, 20, 32 weeks |
| Secondary outcome measures | Side effects were registered using a standardized questionnaire created for the purpose of this study throughout the 31 week study period by healthcare providers. |
| Overall study start date | 01/02/2010 |
| Completion date | 01/02/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 6 Years |
| Sex | Both |
| Target number of participants | 12 |
| Key inclusion criteria | 1. Children aged 4-6 years 2. Diagnosis of cystic fibrosis 3. Clinically stable 4. Undergoing a simple therapy based on bronchodilators and physiotherapy 5. No respiratory infections during the treatment or 2 weeks before |
| Key exclusion criteria | Children with instable medical conditions |
| Date of first enrolment | 01/09/2012 |
| Date of final enrolment | 01/09/2013 |
Locations
Countries of recruitment
- Italy
Study participating centre
Department of Pediatrics and Infantile Neuropsychiatry
V.le Regina Elena 324
Rome
00161
Italy
Sponsor information
University/education
Department of Pediatrics and Pediatric Neuropsychiatry
Viale Regina Elena 324
Rome
00161
Italy
"ROR" |
https://ror.org/02be6w209 |
|---|
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | 01/06/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in the journal BMC Pediatrics |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 15/07/2017 | Yes | No |
Editorial Notes
19/10/2017: Publication reference added.
